Music and Child Health and Development

Parent-Child Relations Clinical Trial

Official title:

A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868811
• Other study ID #: STUDY00002451
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Kai Ling Kong, PhD
• Phone: 866-512-2168
• Email: kkong[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old children from low-income families. The main questions it aims to answer are:

1. Does participation in a music enrichment program improve the quality of parent-child interactions?

2. Does participation in a music enrichment program reduce motivation for food

3. Does participation in a music enrichment program improve the quality of the language environment?

Participants will:

1. Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.

2. At the beginning, after the first 8 weeks and after the second 8 weeks, a researcher will come to the participants house and parent-child pairs will:

1. be video recorded during 10 minutes of playtime and meal time.

2. fill out questionnaires

3. wear a small wearable language recorder for 16 hours

3. At the beginning, after the first 8 weeks and after the second 8 weeks, the parent and child will come to the baby lab and will:

1. Play a computer game to test motivation for food

2. have height and weight measurements collected

Researchers will compare the music and play groups to see if there is a difference in the quality of parent child interaction, food motivation or language environment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 24 Months

Eligibility

Inclusion Criteria:

• Family income meets criteria for the National Women, Infant, and Children (WIC) program

• Family is able and willing to commit to a 6-month program

Exclusion Criteria:

• Mother <18 years old at the time of delivery

• During pregnancy:

• Mother smoked >10 cigarettes/day

• Mother used >1 marijuana joint/day

• Mother used any other illicit drugs

• Mother drank > 3 standard drinks on a single occasion or >1 standard drink on a daily basis

• Preterm birth <37 weeks gestation

• Child with significant health issues, and/or genetic conditions (e.g., cerebral palsy, down's syndrome)

• Mother with major health concerns during pregnancy (e.g., gestational diabetes, pre-eclampsia, etc)

• Parent/child who do not speak English

Related Conditions & MeSH terms

• Language Development
• Obesity, Infant
• Parent-Child Relations
• Pediatric Obesity

Intervention

Behavioral:
• Music Together
The intervention consists of 45-minute weekly classes for 16 weeks. Each class is delivered by a trained Music Together facilitator and includes music activities such as singing, dancing, moving and playing musical instruments. At the start of the program, participants receive materials for home use that consist of a song book and online access code for song recordings used in the class.
• Play Group
The play group consists of 45-minute weekly classes for 16 weeks. During each class parents are encouraged to play with their child and interact with other participants using the provided age appropriate toys. At the start of the program participants receive an age appropriate toy for use at home.

Locations

Country	Name	City	State
United States	ChildrensMHC	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Jackson County Missouri, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline infant food reinforcing ratio at 8 weeks and 16 weeks	Infant will potentially change their food reinforcing ratio (FRR) based on the randomized class.; Name of the measurement: Food reinforcing ratio (FRR) Unit of measure: ratio	Baseline, 8-weeks, 16-weeks
Primary	Change from Baseline conversational turns at 8 weeks and 16 weeks	Parent-child dyads will potentially change their frequency of conversational turns based on the randomized class.; Name of measurement: Conversational turns Unit of measure: frequency count	Baseline, 8-weeks, 16-weeks
Primary	Change from Baseline Quality of parent-child interactions at 8-weeks and 16-weeks	Parent-child dyads will potentially change their quality of interactions based on the randomized class. Name of measurement: The parent child early relational assessment (PCERA) Unit of measure: 5-point global rating scale	Baseline, after semester 1, after semester 2